MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.010

Device Problem Failure to Shut Off (2939)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during sterile processing, it was observed that the small battery drive device would stay engaged even after the trigger was released and the device was turned off.According to the reporter, the only way to stop the device was to remove the battery device.There were no delays to a surgical procedure.It was unknown if a spare device was available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device failed the start stop test, stays running on its own, the coupling head worn, there was an unknown residue/substance found on the internal components, the electric motor emitted an unusual noise and the ball bearings seized.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper cleaning/care and component wear from use and servicing over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMALL BATTERY DRIVE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6060212
• MDR Text Key: 59013017
• Report Number: 8030965-2016-15362
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.010
• Device Lot Number: 3793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1